Treatment of arthritis and other similar conditions

ABSTRACT

Methods for treatment of arthritis are provided, the methods including administering an effective amount of Ngali Nut Oil.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national application of InternationalApplication Ser. No. PCT/AU99/00426, filed Jun. 1, 1999, which claimspriority to Australian Provisional Patent Application No. PP3796 filedJun. 1, 1998.

FIELD OF THE INVENTION

The invention relates to a method for treatment of the manifestations ofarthritis and other similar conditions.

BACKGROUND OF THE INVENTION

Whilst the following discussion concerns the treatment and relief of themanifestations of arthritis, it is to be understood that the sameprinciples apply to the treatment of the manifestations of rheumatism,tendinitis, spondylitis and similar degenerative joint disease.

Rheumatism is a general term which refers to any pain or acheoriginating from the muscles, joints, bones or other parts of themusculoskeletal system. Many people have rheumatic pains which vary fromday to day and sometimes with the weather. Often sufferers report thattheir manifestations are worse when the weather is damp and cold,although other sufferers report the opposite. The reasons for thesefluctuations, and the precise source and mechanism of the pain is notknown.

Arthritis is a more specific term that implies damage or inflammation inone or more joints. The condition is often manifested by pain, swelling,heat, redness and limitation of movement. The most common type ofarthritis is osteoarthritis or ‘wear and tear arthritis’. The conditionresults from the wearing down of cartilage. Since the cartilage cannotbe properly replaced by the body, it may make new bone at the edge ofthe joint to compensate for the loss of cartridge. This in turn producesbony swellings which are painful because the new bone is stretching thesensitive lining of the pre-existing bone. This condition is common inthe fingers.

The cause of osteoathritis is unknown but may include a combination ofchemical, mechanical, hereditary, metabolic, or endocrine factors whichmay damage a joint.

Hereditary osteoarthritis is a hereditary predisposition to a conditionin which fingers and thumbs begin to go out of shape. This in turncauses bony swellings around the joint and the onset of arthritis. Thecondition seems to predominately affect women and manifests duringmenopause.

A genetic predisposition to osteoathritis, in conjunction with damage tothe joint directly or indirectly may result in the condition manifestingitself in larger joints such as the hip and knee. This condition is seenpredominately in men. Some occupations such as farming, and the pursuitof contact sports, have certain inherent risks towards the developmentof hip and knee osteoarthritis. A fracture involving a joint, a severeligamentous injury, or removal of the patella usually results in thelater development of arthritis in the area of damage.

Not as common but far more debilitating, is the condition known asrheumatoid arthritis. This involves the inflammation of the joints andaffects 1 in 10 people. The inflammation starts in the lining of thejoint and results in the release of pain causing substances into thejoint space. It is also an auto immune disease in which the body'simmune system attacks itself. There are many theories on the cause ofrheumatoid arthritis. Although, it is thought a combination ofenvironmental factors (such as infection) and genetic factors may makeindividuals more prone to the disease.

Unfortunately, there is no known way of halting the process of arthritiseither by drugs or other methods. Current treatments include:

1. Joint Protection and Exercise

If a joint is diagnosed as being damaged either with signs of ligamentdamage or early manifestations of arthritis, sufferers are advised toavoid activities that may accelerate the arthritic process and rest thejoint concerned. Dietary and weight loss programs are also prescribed.

Some form of exercise can also prove beneficial. However, because of thepain associated with arthritic manifestations, sufferers are oftenunable to comply with exercise regimes.

2. Drug Treatments

Several types of drugs are currently used in the treatment of arthritisincluding:

Pain Killers/ Analgesics.

These type of drugs are well known and include Aspirin, Paracetamol,Codeine and Diflunisal. They are important in allowing patients withchronic pain to cope with life and in some instances, sleep.Unfortunately these drugs are incapable of taking away the paincompletely. Furthermore, overuse or overdependance can cause otherproblems such as gastrointestinal upsets and hemorrhage, tinnitus,dizziness, and hypersensitivity reactions to the drugs.

Non Steroidal Anti-Inflammatory Drugs

These types of drugs are also well known and include Voltaren,Arthrotec, Naproxen and Ketoprofen. These drugs reduce the formation ofthe prostaglandins responsible for the pain and inflammation associatedwith arthritis. They can reduce pain, swelling, stiffness and improvemobility. Unfortunately, they do not remove the manifestations ofarthritis completely, and do not seem to cure the condition or preventdamage to the joints in the long term. This class of drugs have similarside effects to the Analgesics.

Disease-Modifying Drugs

These drugs are prescribed generally to combat rheumatoid arthritis.They can reduce the level of inflammation in the joints and preventdamage to the joints. Drugs in this class include Gold (Myocrisin),Sulphasalazine and Chloroquine. These drugs are slow acting and in someinstances can take several months before taking effect. Unfortunately, afull cure is rarely achieved, and the treatment may have to be stoppedbecause of the often harsh side effects such as dermatitis, skin rashes,anaphylactic hypersensitivity reactions, anorexia, nausea and vomiting.

Corticosteroids

Corticosteroids or steroids are prescribed to suffers of rheumatoidarthritis in particular. They can be effective in reducing the level ofinflammation or in treating particularly painful arthritic flair ups.There is a reluctance to use, steroids more widely because of the longterm side effects, particularly the suppression of the patient's ownimmune response and the adverse effects to the body's metabolicactivities.

Recently, developments in stronger drugs and techniques which counteractthe negative effects of chemical messengers (interleukins) have givenarthritis sufferers renewed hope. However these drugs are still verymuch in the experimental phase.

Due to the high incidence of arthritis in the community, the financialburden of arthritis on the health system is extremely high.

Unfortunately the current drug regimes used for treating arthritis areonly partially effective and in some instances, the side effects ofcontinual treatment can outweigh the benefits. Unfortunately, dietaryand exercise regimes have only limited application and are difficult tomanage because of poor patient compliance.

In light of the inherent problems of current drug regimes, naturalremedies are beginning to gain favor amongst arthritis suffers as analternative means of treating their often painful manifestations.Natural remedies may therefore play an important role in relieving themanifestations of arthritis and because of a lack of side effects mayresult in better patient compliance.

Current natural remedies include Sea Cucumber Extract, Shark Cartilage,Green Lipped Mussel, Evening Primrose Oil and Cod Liver Oil. Howeverthere is no conclusive evidence that these remedies make muchdifference. Evening Primrose Oil and Cod Liver Oil are the most popularof the natural remedies and the ones with the best rationale ofbeneficial activity. It is possible that these remedies may alter thebalance of the chemicals in the pain pathway in a favorable manner.

Accordingly, an investigation was made into the possibility of othernatural remedies which could treat the painful manifestations ofarthritis without some of the unwanted side effects associated withcurrent drug regimes.

OBJECT OF THE INVENTION

It is an object of the invention to provide a method for treatment ofthe manifestations of arthritis using a naturally available composition.

SUMMARY OF THE INVENTION

It has surprisingly been found that an extract of Ngali Nut Oil can beeffective in treating the manifestations of arthritis.

According to one form of the invention there is provided a method fortreatment of the manifestations of arthritis in a mammal, including ahuman, by administering an effective amount of Ngali Nut Oil.

Preferably the Ngali Nut Oil is administered alone, or in combinationwith at least one other therapeutic agents used for treatment of themanifestations of arthritis. This may include compatible drugs.

Preferably the Ngali Nut Oil is administered topically to the epithelialsurface of an area effected by manifestations of arthritis. The NgaliNut Oil can be reapplied depending on the severity of the manifestationsof arthritis.

According to another preferred form of the invention, the Ngali Nut Oilcan be administered orally. The Ngali Nut Oil can be further orallyadministered depending on the severity of the manifestations ofarthritis.

According to another form of the invention, a Ngali Nut Oil compositionfor topical administration is provided comprising:

a) not in excess of about 50% of a stable cream base; and

b) not in excess of about 50% Ngali Nut Oil.

The Ngali Nut Oil is mixed with the stable cream to form an emulsion.The stable cream acts as a base to facilitate the absorption of theNgali Nut Oil into an epithelial surface of an area effected by themanifestations of arthritis.

There are several stable cream bases which may be used, these are wellknown to those skilled in the art.

One example of a stable cream base is Sorbolene Cream.

Preferably the percentage of Ngali Nut Oil is approximately 5%.

Typically, the composition of the present invention can be made byconventional compounding procedures known in the pharmaceutical art toprovide a topically administered ointment, cream or paste.

According to another preferred form of the invention, a Ngali Nut Oilcomposition for oral administration is provided for the treatment of themanifestations of arthritis comprising an effective amount of Ngali NutOil.

The present invention provides a composition and a physiologicallyacceptable carrier suitable for oral administration.

For example, by mixing the active substance with edible physiologicallyacceptable, non toxic, inert, solid or liquid carriers and/or expicientssuitable for systemic administration and conventionally used in oraldosage forms.

EXAMPLE

The invention will now be further explained and illustrated by thefollowing non-limiting example.

Ngali Nut Oil is the oil obtained from the nuts of several varieties ofNgali Nut Trees grown in the Solomon Islands, Vanuatu Papua New Guineaand the Philippines. The three most common varieties of Ngali Nut Treesare Canarium Indicium, Canarium Solomonesis and Canarium Harveyi. Atthis stage no work has been done in creating hybrids of the Canariuspecies.

It will be understood by those skilled in the art that the currentinvention is not restricted to the aforementioned varieties of Ngali NutTree and includes any hybrids thereof.

The average oil content of the Ngali Nut is 74%, of which 48% issaturated fat. The type of fatty acids found are similar to Palm Oil,but with higher levels of stearic and linoleic acids.

TABLE 1 Ngali Nut Oil Analysis. C. Harveyi C. Indicum C. Salomonense (%)(%) (%) TOTAL OIL CONTENT¹ 73.6 74.9 73.6 FREE FATTY ACID .1 .2 CONTENTFATTY ACID COMPOSITION Lauric (C12:1) .4 Myristic (C14:1) .1 .2 Palmitic(C16:1) 36.6 34.3 34.9 Palmitoleic (C16:1) .7 .4 Heptadecanoic (C17:1).1 .2 Stearic (C18:1) 10.7 13.4 12.6 Oleic (C18:1) 26.3 37.5 41.6Linoleic (C18:1) 24.5 13.5 10.3 Linolenic (C18:1) .3 .3 .4 Arachidic(C20:1) .3 .3 .2 Eicosenoic (C20:1) .1 .1 Behenic (C22:1) .1 Saturated47.9 48.5 47.7 Monosaturated 27.2 37.8 41.6 Polyunsaturated 24.8 13.710.7

The Ngali Nut Tree is harvested to remove the Ngali Fruit. To extractthe nut, the skin from the Ngali Fruit is removed and the in-shell nutsdried. The nuts are then cracked open to extract the kernel which isthen pressed to extract the Ngali Nut Oil.

1. Composition

The composition tested comprised 5% Ngali Nut Oil and 95% of the stablecream base Sorbolene Cream.

2. Subjects

Six subjects, four males and two females, were recruited for thisexperiment aged between 50 to 89 years. The subjects suffered from, andhad been diagnosed with most common varieties of arthritis includingosteoarthritis and rheumatoid arthritis and exhibited typical arthriticmanifestations including pain and inflammation of the joints.

In some instances, the subjects were already taking other medicationincluding Analgesics, Non Steroidal Anti Inflammatory Drugs, DiseaseModifying Drugs and Corticosteroids. The subjects maintained anypre-existing drug regimes.

3. Administration Regime

Initially, the subjects were instructed to apply a small amount of theNgali Nut Oil composition twice daily, morning and night by rubbing itinto the skin until all the composition was absorbed. When the arthriticpain began to dissipate the subjects were instructed to cut back theapplication and apply only when they felt a recurrence of pain. In mostinstances this resulted in a twice weekly or weekly application.

4. Assessment

The subjects were instructed to assess any change in the level of anyarthritic manifestation. For the purposes of the experiment thearthritic manifestations were assessed by reference to the level of painand immobility in the arthritic joint and the general well being of thesubject. The last criteria encompassed both the physical and mentalstate of the subject.

5. Application of Ngali Nut Oil Composition

The Ngali Nut Oil composition was applied topically to the hands of thesubject. The subject then proceeded to rub the composition until it wasabsorbed. Where possible, the hands were used as the test site becauseit is a part of the body which most readily shows signs of themanifestations of arthritis. Also, there is little surrounding tissuewhich the Ngali Nut Oil composition must penetrate in- order to reachthe area exhibiting arthritic manifestations. Thus the Ngali Nut Oilcomposition could be absorbed quickly through the skin and reach thearthritic joints.

After initial application the subjects assessed the level of arthriticmanifestations namely the level of pain, mobility and general well beingon a weekly basis.

The Ngali Nut Oil composition was reapplied the same day, and appliedtwice daily there after, for a period of at least 2 weeks.

6. Results

In some instances, the subjects observed that the application of theNgali Nut Oil composition resulted in a readily apparent reduction inthe level of pain and immobility.

After two weeks of an initial twice daily application, subjects 1, 2, 3and 4 showed a marked improvement in the reduction of arthriticmanifestations.

At this point these subjects reduced the application of the Ngali NutOil composition to instances when the artitic manifestations began tore-emerge. Often this would result in weekly or twice weeklyapplications.

In the case of subjects 5 and 6, the marked improvement took longer thantwo weeks to show. They continued the application of Ngali Nut Oilcomposition twice daily until they also experienced a marked improvementin the incidence of arthritic manifestations. They then reduced theapplication of Ngali Nut Oil composition to instances when the arthriticmanifestations began to re-emerge. This again resulted in weekly ortwice weekly applications.

In all instances there was a decrease in the level of arthriticmanifestations.

Subject 1 stopped the application of the Ngali Nut Oil composition after4 weeks. He found that it took two months until the arthriticmanifestations returned to their pre application level. This mayindicate that the Ngali Nut Oil composition has some residual effect.

Subjects 3 and 4 showed signs of arthritic manifestations in both theirhands, and in other parts of their body such as knees shoulder and backand ankles. After the Ngali Nut Oil composition had been applied twicedaily for two weeks to their hands, these subjects reported that otherareas effected by arthritic manifestations also began to show areduction in these manifestations, specifically pain and immobility.

These subjects then applied a small amount of the Ngali Nut Oilcomposition directly to the area exhibiting arthritic manifestationstwice daily, in the morning and in the evening. This led to a furtherdecrease in the level of arthritic manifestations experienced by thesubjects on the secondary areas of arthritic manifestations. This mayindicate that the Ngali Nut Oil may have some systemic effect.

TABLE 2 Summary of Results Period until Location some relief ApproxExisting of Arthritic from Arthritic Residual Systemic Subject Sex ageType of pain medication Manifestation Manifestation effect effect  1* M62 Osteoarthritis NA Fingers 1 hour Yes Yes 2 M 60 Osteoarthritis NAHand 2 days Yes NA 2 M 60 Osteoarthritis NA Lower back 1 hour Yes NAStrain 3 M   60+ Rheumatoid Predmisone All joints 1 hour Yes YesArthritis Methotrexate Rodocol Indomethacin 4 F 89 Arthritis Multi Hand,2 days Yes Yes shoulders, knees 5 M 60 Osteoarthritis NA Wrist, 8 weeksYes Yes Knee 12 hours Yes 6 F 50 Non-arthritic Steroid Wrist 8 weeks YesNA Injections *Subject 1 stopped taking the Ngali Nut Composition, whichlead to a return of the arthritic manifestations.

The above results indicate that Ngali Nut Oil can reduce themanifestations of arthritis.

The word ‘comprising’ and forms of the word ‘comprising’ as used in thisdescription and in the claims does not limit the invention claimed toexclude any variants or additions.

Modifications and improvements to the invention will be readily apparentto those skilled in the art. Such modifications and improvements areintended to be within the scope of this invention.

What it claimed is:
 1. A method for treatment of the manifestations ofarthritis in a mammal by administering an effective amount of Ngali NutOil.
 2. The method according to claim 1 wherein the Ngali Nut Oil isadministered in combination with at least one other therapeutic agentused for treatment of the manifestations of arthritis.
 3. The methodaccording to claim 1 wherein the Ngali Nut Oil is administered topicallyto the epithelial surface of an area affected by the manifestations ofarthritis.
 4. The method according to claim 3 wherein the Ngali Nut Oilis reapplied depending on the severity of the manifestations ofarthritis.
 5. The method according to claim 1 wherein the Ngali Nut Oilis administered orally.
 6. The method according to claim 5 wherein theNgali Nut Oil is orally re-administered depending on the severity of themanifestations of arthritis.
 7. The method according to claim 1 whereinthe Ngali Nut Oil is administered topically in a composition comprising:a) a stable cream base; and b) not in excess of about 50% by weight ofNgali Nut Oil.
 8. The method according to claim 7 wherein the stablecream base is Sorbolene Cream.
 9. The method according to claim 7wherein the amount of Ngali Nut Oil is by weight approximately 5%. 10.The method according to claim 1 wherein the Ngali Nut Oil isadministered orally in a composition comprising: a) an effective amountof Ngali Nut Oil; and b) a physiologically acceptable carrier suitablefor oral administration.
 11. The method according to claim 1 wherein themammal is a human.
 12. A method for treatment of the pain and immobilityof arthritis in a mammal comprising the step of administering aneffective amount of Ngali Nut Oil to the mammal.
 13. The method of claim12 wherein the Ngali Nut Oil is administered topically to an epithelialsurface of an area affected by pain and immobility of arthritis.
 14. Themethod of claim 13 further comprising the step of reapplying the NgaliNut Oil in a frequency sufficient to maintain reduction of the pain. 15.The method of claim 12 wherein the Ngali Nut Oil is administered orally.